MD210C3 21.3 Diagnostic Imaging LCD Monitor

FDA 510(k) K142951 · Nec Display Solutions , Ltd.

Substantially Equivalent

510(k) numberK142951

Submission

Device name
MD210C3 21.3 Diagnostic Imaging LCD Monitor
Applicant
Nec Display Solutions , Ltd.
Tokyo, JP
Received
October 10, 2014
Decision date
December 10, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PGY – Display, Diagnostic Radiology
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.

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More from Eizo Corporation

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K130772MD211C2 21.3 Diagnostic Imaging LCD MonitorLLZ · Traditional 04/18/2013SE
K130770MD211C3 21.3 Diagnostic Imaging LCD MonitorLLZ · Traditional 04/18/2013SE
K111237MD301C4 29.8 Diagnostic Imaging LCD Monitor, L309TYLLZ · Traditional 06/15/2011SE
K090218MD213MC 21.3 Diagnostic Imaging LCD Monitor Model, L218TJLLZ · Traditional 04/15/2009SE
K090215MD213MG 21.3 Diagnostic Imaging LCD Monitor - L218TLLLZ · Traditional 04/15/2009SE
K083916LCD3090WQXI or MD304MC 29.8 Inch Diagnostic Imaging LCD Monitor, Model L307TDLLZ · Traditional 01/14/2009SE
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Questions and answers

When was MD210C3 21.3 Diagnostic Imaging LCD Monitor cleared by the FDA?

MD210C3 21.3 Diagnostic Imaging LCD Monitor (K142951) received a 510(k) decision of Substantially Equivalent on December 10, 2014, 61 days after the submission was received.

What is the product code of K142951?

The FDA product code is PGY – Display, Diagnostic Radiology, a Class II (moderate risk) device regulated under 21 CFR 892.2050.